Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms

Status Recruiting

Clinical Trial Summary

This project proposes to conduct the first fully controlled and randomized clinical study demonstrating the impact of DPA-rich sea bass oil on the reduction of symptoms related to rheumatoid arthritis. This unique approach will allow to clinically evaluate the benefits of sea bass oil on the relief of rheumatoid arthritis-related pain in a population suffering from inflammatory arthritis.

Clinical Trial Description

The main objective of this project is to measure the efficacy of DPA-rich marine seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis through the score calculated from the Rheumatoid Arthritis Disease Activity Index (RADAI) questionnaire, in patients suffering from this disease. The secondary objectives are to evaluate the effect of DPA-rich seal oil on: 1. the degree of disease activity as measured by a joint examination performed by the physician 2. the patient's overall health, quality of life and level of fatigue 3. blood biomarkers of inflammation (CRP: c-reactive protein, TNF-: tumor necrosis factor, IL-1, IL-6 and IL-17: interleukin); 4. the use of non-steroidal anti-inflammatory drugs (NSAIDs); 5. the occurrence of side effects. To do so, the proposed study is a multi-center, randomized, double-blind, parallel-designed study involving 130 participants with a previous diagnosis of RA from two research and treatment centers in Quebec: the "Groupe de recherche en rhumatologie et maladies osseuses" (GRMO Inc.) from Québec and the "Centre de recherche musculo-squelettique" (CRMS) from Centre du Québec. Rheumatologists from each of the centers, as well as research nurses, will be involved in this project, which will be coordinated by a research professional from the Institut sur la nutrition et les aliments fonctionnels (INAF) at Université Laval. Half of the participants (n=65) will randomly receive the experimental treatment (marine seal oil) while the other half will receive the control treatment (vegetable oil). In order to reach a minimum blood concentration of omega-3 fatty acids for measurable effects, the experimental and control treatments will be administered over a 12-week period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04688398
Study type	Interventional
Source	Laval University
Contact	Louise Corneau, MSc
Phone	418-656-2131
Email	louise.corneau@fsaa.ulaval.ca
Status	Recruiting
Phase	N/A
Start date	January 20, 2022
Completion date	March 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms